Label: CVS HEALTH FOUR ACTIONS NASAL DECONGESTANT- phenylephrine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 22, 2016

If you are a consumer or patient please visit this version.

  • Active ingredient

    Phenylephrine hydrochloride 1%

  • Purpose

    Nasal decongestant

  • Uses

    for the temporary relief of nasal congestion due to:

    common cold
    hay fever
    upper respiratory allergies
  • Warnings

  • Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland.
  • When using this product

    do not exceed recommended dosage

    • do not use more than 3 days. Use only as directed.

    • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

    • the use of this container by more than one person may spread infection

    • frequent or prolonged use may cause nasal congestion to recur or worsen

  • Stop use and ask a doctor

    if symptoms persist.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

  • Directions

    adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more than every 4 hours
    children under 12 years of age: ask a doctor
    Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
  • Other information

    store between 20°-25°C (68°-77°F)
    container is filled to proper level for best spray action
  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate

  • Principal Display

    CVS Health

    NDC 59779-838-30

    Compare to the active ingredient 4-Way® Nasal Spray*

    Fast-Acting

    Nasal Spray

    PHENYLEPHRINE HCl 1%

    Nasal decongestant

    FOUR ACTIONS

    Relieves:

    Nasal congestion
    Sinus congestion
    Sinus pressure
    Swollen nasal membranes

    1 FL OZ (30 mL)

    DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., the owner of the registered trademark 4-Way® Nasal Spray.

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2015CVS/pharmacy

    CVS.com®

    1-800-SHOP CVS

    CVS® Quality

    Money back Guarantee

    CVS Health Nasal Spray Phenylephrine HCl 1% Four Actions  1 FL OZ
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH FOUR ACTIONS NASAL DECONGESTANT 
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-838
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-838-301 in 1 CARTON04/01/2015
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2015
    Labeler - CVS Pharmacy,Inc. (062312574)